Product Development and Marketing
Lee has nearly 30 years of legal experience counseling life sciences companies both in private practice and as corporate counsel. Before her association with Faegre Baker Daniels, she was Associate General Counsel for Eli Lilly and Company, working with laws and regulations related to development and marketing of pharmaceuticals in a variety of disease state areas. Lee advises companies in developing, researching and obtaining necessary regulatory clearances and approvals for their medical devices, drugs (including OTC), biologics, tissue (HCT/Ps) and combination products (drug/device). Lee works with major pharmaceutical, biotech and medical device manufacturers, as well as startup ventures, providing advice on product labeling and advertising matters, including social media tactics and use of endorsements/testimonials.
Compliance is another area of focus in Lee's practice. She conducts training and advises on compliance issues, including development of internal compliance plans, as well as FDA and fraud and abuse issues associated with use of advisors/consultants, discount/rebate/coupon practices, grants and support of CME, and medical affairs and medical information functions. Lee assists clients with federal and state reporting and transparency laws such as the Physician Payments Sunshine Act (U.S. Open Payments). Lee also works on a variety of commercial agreements for life sciences clients, including clinical research, product and services supply agreements, as well as agreements and regulatory due diligence associated with mergers, acquisitions and strategic alliances.
Lee and her husband recently returned from living in Basel, Switzerland. Lee loves to travel and enjoy new foods and cultures. She is an avid fan of podcasts and is always looking for a new one to follow!